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Идёт набор NCT06866730

Effect of Using an Object Handling Serious Game on Upper Limb Rehabilitation for Children with Neurological Disorders

Без фазы С лечением Neurologic Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Serious game.
Кому может быть актуально
Состояния в реестре: Neurologic Disorder. Базовые параметры: 4 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Effect of Intensive Repetitive Motor Training in Toy Manipulation Supported by Gamified Physical Training Software in Children and Adolescents with Neurological Disorders Impacting Motor Skills

Обзор

Cerebral palsy, and more broadly neurological disorders, can lead to significant motor impairments that impact individuals' daily lives. To address these limitations, the French National Authority for Health has issued recommendations for rehabilitative care, highlighting intensive training programs, physical activity, and interactive computer games. Scientific literature has also demonstrated the benefits of therapies that incorporate repetition. In this study, the investigators aimed to train patients in producing grasp-and-release movements, and more broadly \*reach-to-grasp\* actions, in a manner intensified by movement repetition. To mitigate the boredom inherent to such repetitive tasks, the invesigators developed a device resembling a serious game, equipped with software, a modular physical platform, and two instrumented figurines designed to interact with the software. Intensive therapy through repetitive movements, supported by the engaging nature of serious games, is expected to improve the manual skills of children with neurological disorders causing motor impairments. To test this hypothesis, a cohort of 5 to 10 children aged 4 to 17 years with neurological disorders causing motor impairments will be invited to participate in the protocol. Participants will first undergo a baseline assessment, which will include repeated measurements of their score on the \*Box and Blocks Test\* and the active range of motion (AROM) of the wrist in extension and supination. An \*Assisting Hand Assessment (AHA)\* test will also be conducted. Following this, a 4-week intervention will be implemented, consisting of three 40-minute sessions per week. During these sessions, the child will play the game and complete the \*Box and Blocks Test\* as well as active range of motion assessments. In total, approximately 4 hours of gameplay is estimated over the course of the intervention, which will conclude with a repeat of the AHA test. A follow-up assessment will take place two months after the intervention's end, with a single measurement of the three parameters (\*Box and Blocks Test\*, AROM, and AHA).

Вмешательства

  • Устройство Serious game
    Serious game in which participants manipulate instrumented toys

Первичные конечные точки

  • Box and Blocks test [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Active Range of Motion [Срок оценки: 3 months]
  • Assisting Hand Assessment [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • Neurological disorder causing motor impairment
  • Age 4 to 17 years old
  • MACS level I to III
  • Ability to cooperate, understand, and follow simple instructions to play the game.
  • Patient affiliated with the French social security system.
  • Voluntary patient whose parents have given consent for their child to participate in the study.

Критерии исключения

  • A diagnosis of photosensitive epilepsy mentioned in the medical record AND/OR a note in the child's medical record or reported by the parents of a history of seizures triggered by video game use.
  • Botulinum toxin treatment within the 3 months prior to the study or intensive rehabilitation of manual skills (e.g., mCIMT, HABIT, etc.).
  • Sensory and/or cognitive impairments that would interfere with playing the game.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Франция · 2 центра
  • CRMTP Elisatbeth de la Panouse-Debré — Antony
  • Fondation Ellen Poidatz — Saint-Fargeau-Ponthierry

Идентификаторы

NCT: NCT06866730 · REPLAY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗